UK guidelines on oesophageal dilatation in clinical practice

Sarmed S Sami,1 Hasan N Haboubi,2 Yeng Ang,3,4 Philip Boger,5 Pradeep Bhandari,6
John de Caestecker,7 Helen Griffiths,8 Rehan Haidry,9 Hans-Ulrich Laasch,10
Praful Patel,5 Stuart Paterson,11 Krish Ragunath,12 Peter Watson,13 Peter D Siersema,14
Stephen E Attwood15
Gut: first published as 10.1136/gutjnl-2017-315414 on 24 February 2018. Downloaded from http://gut.bmj.com/ on 26 June 2018 by guest. Protected by copyright.

ABSTRACT

These are updated guidelines which supersede the original version published in 2004. This work has been endorsed by the Clinical Services and Standards Committee of the British Society of Gastroenterology (BSG) under the auspices of the oesophageal section of the BSG. The original guidelines have undergone extensive revision by the 16 members of the Guideline Development Group with representation from individuals across all relevant disciplines, including the Heartburn Cancer UK charity, a nursing representative and a patient representative. The methodological rigour and transparency of the guideline development processes were appraised using the revised Appraisal of Guidelines for Research and Evaluation (AGREE II) tool.

Dilatation of the oesophagus is a relatively high-risk intervention, and is required by an increasing range of disease states. Moreover, there is scarcity of evidence in the literature to guide clinicians on how to safely perform this procedure. These guidelines deal specifically with the dilatation procedure using balloon or bougie devices as a primary treatment strategy for non-malignant narrowing of the oesophagus. The use of stents is outside the remit of this paper; however, for cases of dilatation failure, alternative techniques—including stents—will be listed. The guideline is divided into the following subheadings: (1) patient preparation; (2) the dilatation procedure; (3) aftercare and (4) disease-specific considerations.

A systematic literature search was performed. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) tool was used to evaluate the quality of evidence and decide on the strength of recommendations made.

SUMMARY OF RECOMMENDATIONS

Patient preparation

  1. Predilatation investigations

1.1 Obtain biopsy specimens from all strictures for histological analysis to exclude malignancy and eosinophilic oesophagitis (GRADE of evidence: moderate; strength of recommendation: strong).

1.2 Repeat biopsy after cross-sectional imaging (computed tomography (CT) or endoscopic ultrasound (EUS)) in cases where biopsies are negative, but clinical or endoscopic features are atypical or suspicious for malignancy (GRADE of evidence: low; strength of recommendation: strong).

1.3 Obtain oesophageal biopsy specimens in young patients with dysphagia or history of food impaction to exclude eosinophilic oesophagitis (GRADE of evidence: moderate; strength of recommendation: strong).

1.4 Perform barium swallow in patients with suspected complex strictures (such as post-radiation therapy or history of caustic injury) in order to establish the location, length, diameter and number of strictures (GRADE of evidence: low; strength of recommendation: strong).

  1. Information and consent

2.1 Counsel all patients about the benefits and risks of dilatation and the likely need for multiple sessions before symptom resolution can be achieved (GRADE of evidence: low; strength of recommendation: strong).

2.2 Tailor information to the individual patient’s risk profile, based on the underlying cause, location, length and diameter of the stricture and coexistent adverse health problems (GRADE of evidence: low; strength of recommendation: strong).

2.3 Provide all patients with written information on oesophageal dilatation before the procedure and obtain written, signed consent. Inform patients about the perforation risk and the potential need for endoscopic or operative intervention should a perforation occur (GRADE of evidence: low; strength of recommendation: strong).

2.4 Inform patients—whenever appropriate—of any alternatives to dilatation, such as parenteral feeding or surgery in some cases (GRADE of evidence: low; strength of recommendation: strong).

2.5 Do not perform oesophageal dilatation in patients with active or incompletely healed oesophageal perforation as it may extend the oesophageal defect and promote mediastinal soiling (GRADE of evidence: low; strength of recommendation: strong).

2.6 Perform dilatation in patients with a recent, healed perforation; recent upper gastrointestinal surgery; pharyngeal or cervical deformity; or bleeding disorders after careful consideration of the benefits, risks and alternatives of the procedure (GRADE of evidence: low; strength of recommendation: strong).

  1. Fasting

3.1 Advise patients to fast for at least 6 hours before the procedure in order to ensure emptying of the oesophagus and stomach. Patients with achalasia are likely to have oesophageal stasis and are therefore required to fast for a longer time based on the clinician’s judgement (GRADE of evidence: low; strength of recommendation: strong).

  1. Patient premedication

4.1 Inform patients that dilatation is likely to be uncomfortable, in particular, when push dilators are used rather than dilatation balloons (GRADE of evidence: low; strength of recommendation: strong).

4.2 Offer patients intravenous sedation with a benzodiazepine and an opioid analgesic as a minimum. Propofol sedation (delivered by a suitably qualified person), or a general anaesthetic are valid alternatives based on the clinician’s and patient’s preference, procedure complexity as well as local availability and expertise (GRADE of evidence: low; strength of recommendation: strong).

The dilatation procedure

  1. Personnel, training and equipment

1.1 Oesophageal dilatation should be undertaken only by (or under direct supervision of) an experienced operator who performs sufficient numbers to maintain their skills. The operator should be supported by at least two assistants (one of whom must be a trained nurse) in the endoscopy/radiology room (GRADE of evidence: moderate; strength of recommendation: strong).

1.2 Ensure that trainees performing dilatation have adequate knowledge and understanding of the indications for, contraindications to, and complications of, this therapeutic procedure. An understanding of the steps for recognition and management of complications is required. Trainees should be familiar with different dilatation techniques as well as alternative and complementary treatment options (GRADE of evidence: moderate; strength of recommendation: strong).

1.3 Perform the procedure in a dedicated, fully equipped endoscopy room with access to X-ray screening and surgical support, or a similarly equipped radiological suite (GRADE of evidence: moderate; strength of recommendation: strong).

1.4 Units must have an agreed protocol to follow in case of a perforation with clear identification of a qualified surgeon (on or off site) to manage this complication in cases where luminal treatment, such as a covered stent, is not feasible or appropriate (GRADE of evidence: low; strength of recommendation: strong).

  1. Oesophageal dilators

2.1 Use either balloon or wire guided bougie dilators to perform oesophageal dilatation (GRADE of evidence: high; strength of recommendation: strong).

  1. The dilatation technique

3.1 Consider limiting the initial dilatation to 10-12 mm in diameter (corresponding to 30-36F) in cases of very narrow strictures not passable by the adult gastroscope. The target for filiform strictures should be even lower (<9mm) (GRADE of evidence: very low; strength of recommendation: weak).

3.2 Consider using no more than three successively larger diameter increments in a single session for both bougie and balloon dilators. The precise restriction of 3×1 mm diameter increments is not evidence based (GRADE of evidence: low; strength of recommendation: low).

3.3 Use wire-guided (bougie or balloon) or endoscopically controlled (balloon) techniques for all patients to enhance safety (GRADE of evidence: moderate; strength of recommendation: strong).

3.4 Do not use weighted (Maloney) bougies with blind insertion, because safer dilators are available (GRADE of evidence: high; strength of recommendation: strong).

3.5 Perform dilatation without fluoroscopy for simple strictures as efficacy and safety have been shown in several studies (GRADE of evidence: moderate; strength of recommendation: strong).

3.6 Use fluoroscopic guidance to enhance safety during dilatation of strictures that are either high risk (such as post-radiation and caustic); cannot be passed en-doscopically and are long; angulated; or multiple (GRADE of evidence: moderate; strength of recommendation: strong).

3.7 Perform repeat endoscopy or injection of contrast after dilatation in cases where perforation is suspected, to consider immediate treatment with a fully covered self-expanding metal stent (SEMS) (GRADE of evidence: low; strength of recommendation: strong).

3.8 Use carbon dioxide insufflation instead of air during endoscopy whenever possible, in complex strictures to minimise luminal distension and postprocedural pain (GRADE of evidence: high; strength of recommendation: strong).

3.9 Consider upper oesophageal sphincter dilatation in the treatment of dysphagia with disordered upper oesophageal sphincter opening, post-cricoid web, cricopharyngeal bar with or without the presence of a Zenker’s diverticulum, or to permit passage of radiofrequency ablation (RFA) catheters (GRADE of evidence: moderate; strength of recommendation: strong).

  1. Aftercare and follow-up

4.1 Monitor patients for at least 2 hours in the recovery room and provide clear written instructions with advice on fluids, diet and medications after the procedure (GRADE of evidence: moderate; strength of recommendation: strong).

4.2 Do not perform imaging and contrast studies routinely after the procedure, unless patients—during recovery—develop persistent chest pain, fever, breathlessness or tachycardia (GRADE of evidence: very low; strength of recommendation: weak).

4.3 Ensure that patients are well and tolerating water on leaving the hospital (GRADE of evidence: low; strength of recommendation: strong).

4.4 Suspect perforation when patients develop pain, breathlessness, fever or tachycardia. Transient chest pain is not uncommon following dilatation but persistent pain should prompt a CT scan with oral contrast to look for perforation (GRADE of evidence: low; strength of recommendation: strong).

4.5 Perform endoscopic re-inspection if the patient becomes symptomatic while in the procedure room, in order to assess for the presence of perforation and to undertake treatment which may include immediate endoscopic stent placement (GRADE of evidence: low; strength of recommendation: strong).

4.6 Provide patients with contact information for the on-call team should they experience chest pain, breathlessness or become unwell (GRADE of evidence: low; strength of recommendation: strong).

4.7 Perform weekly or two-weekly dilatation sessions until easy passage of a >15 mm dilator is achieved along with symptomatic improvement (GRADE of evidence: moderate; strength of recommendation: strong).

Disease-specific considerations

  1. Achalasia dilatation

1.1 Perform dilatation with pneumatic balloons 30-40 mm in diameter starting at 30 mm in the first session to reduce the risk of complications (GRADE of evidence: high; strength of recommendation: strong).

1.2 Perform a second dilatation session 2-28 days later with a larger size balloon of 35 mm (GRADE of evidence: high; strength of recommendation: strong).

1.3 Consider repeat dilatation (after the initial series) during follow-up to maintain symptom response (GRADE of evidence: high; strength of recommendation: strong).

1.4 Perform dilatation under endoscopic or fluoroscopic control based on clinician’s preference and local expertise (GRADE of evidence: moderate; strength of recommendation: strong).

1.5 Consider proton pump inhibitor (PPI) therapy after dilatation as the technique has 10-40% rate of symptomatic gastro-oesophageal reflux disease (GORD) or ulcerative oesophagitis after treatment (GRADE of evidence: high; strength of recommendation: strong).

1.6 Consider performing a water-soluble contrast swallow after dilatation to screen for perforation, but it is not essential (GRADE of evidence: moderate; strength of recommendation: weak).

  1. Peptic strictures

2.1 Offer PPI therapy to patients with GORD and dysphagia, as this treatment has been shown to reduce the need for oesophageal dilatation (GRADE of evidence: high; strength of recommendation: strong).

2.2 Offer PPI therapy after endoscopic dilatation for peptic strictures in order to reduce recurrence rate (GRADE of evidence: high; strength of recommendation: strong).

2.3 Offer PPI therapy rather than H2 receptor antagonists, which are ineffective in reducing the need for repeat dilatation (stricture recurrence), less effective in healing of oesophagitis and in providing symptom relief from GORD and dysphagia (GRADE of evidence: high; strength of recommendation: strong).

  1. Schatzki’s ring

3.1 Do not offer dilatation for asymptomatic Schatzki’s rings incidentally discovered on diagnostic endoscopy or contrast studies (performed for unrelated indication) (GRADE of evidence: low; strength of recommendation: strong).

3.2 Consider exclusion of eosinophilic oesophagitis by distal, mid and proximal oesophageal biopsies in symptomatic Schatzki’s ring (GRADE of evidence: moderate; strength of recommendation: strong).

3.3 Offer a single dilatation session using graded dilatation to a relatively large diameter (16-20 mm) to treat dysphagia related to Schatzki’s ring (GRADE of evidence: moderate; strength of recommendation: strong).

3.4 Offer PPI therapy after dilatation, as this reduces the risk of relapse of Schatzki’s ring (GRADE of evidence: moderate; strength of recommendation: strong).

3.5 Consider electrosurgical incision as an effective alternative treatment to oesophageal dilatation for relieving dysphagia related to Schatzki’s ring (GRADE of evidence: high; strength of recommendation: strong).

  1. Post-endoscopic therapy strictures

4.1 Inform patients of up to ~50% chance of developing symptomatic stricture requiring endoscopic dilatation after endoscopic resection (ER) either following endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) in any of the following situations: resection size >75% of the oesophageal circumference; and a longitudinal resection length of >40 mm (GRADE of evidence: high; strength of recommendation: strong).

4.2 Offer dilatation for the management of symptomatic post-mucosal resection strictures (GRADE of evidence: moderate; strength of recommendation: strong).

4.3 Inform patients that perforation rates of dilatation for post-ER strictures in the oesophagus can be up to 1.1% (GRADE of evidence: moderate; strength of recommendation: strong).

4.4 Offer fully covered SEMS in carefully selected patients for the dilatation of refractory strictures after ER (GRADE of evidence: low; strength of recommendation: weak).

4.5 Consider steroid injection at the resection site or oral prednisolone therapy in patients at high risk after large EMR or ESD to reduce stricture formation (GRADE of evidence: moderate; strength of recommendation: weak).

4.6 Offer fully covered SEMS in carefully selected patients for the prevention of refractory strictures after ESD of large lesions, placing the stent at the same time as the first stricture dilatation (GRADE of evidence: moderate; strength of recommendation: weak).

4.7 Inform patients that stricture formation requiring dilatation is significantly higher in the following situations: after photodynamic therapy (PDT) (36%) compared with other forms of ablation; where ER has preceded ablation (12% vs 6%); with use of higher doses of energy with RFA for Barrett’s oesophagus (BO); and after RFA for early squamous cell neoplasia (14-23%) (GRADE of evidence: moderate; strength of recommendation: strong).

4.8 Offer dilatation in patients with clinically significant stricture formation after RFA, with or without previous ER (GRADE of evidence: moderate; strength of recommendation: strong).

4.9 Offer PPI therapy after ER or ablation to reduce stricture occurrence (GRADE of evidence: low; strength of recommendation: strong).

  1. Eosinophilic oesophagitis

5.1 Offer dilatation along with other forms of disease modification using diet, topical steroids or other drugs (GRADE of evidence: moderate; strength of recommendation: strong).

5.2 Start other treatments for eosinophilic oesophagitis (EoE) before dilatation if possible, and those may be continued afterwards to prevent or delay recurrence of symptoms (GRADE of evidence: moderate; strength of recommendation: strong).

5.3 Offer preliminary topical steroids followed by dilatation as this is more cost-effective than using dilatation alone as first-line treatment (GRADE of evidence: moderate; strength of recommendation: strong).

5.4 Offer dilatation as first-line treatment in patients with acute symptoms such as food bolus obstruction and daily dysphagia (GRADE of evidence: moderate; strength of recommendation: strong).

5.5 Offer dilatation to patients with established tight stricture, narrow calibre oesophagus and those who do not respond to diet or drugs (GRADE of evidence: high; strength of recommendation: strong).

5.6 Reassure patients that dilatation of EoE is no more dangerous than dilatation for other oesophageal diseases, and the perforation rates are similar (GRADE of evidence: high; strength of recommendation: strong).

5.7 Inform patients with EoE that chest pain after dilatation is common (GRADE of evidence: high; strength of recommendation: strong).

5.8 Inform patients that symptom response after dilatation usually lasts up to 1year (GRADE of evidence: moderate; strength of recommendation: strong).

5.9 Repeat dilatation if needed (GRADE of evidence: high; strength of recommendation: strong).

5.10 Consider the use of special techniques such as Endo-FLIP and Balloon pull through to judge the optimal calibre and position of dilatation (GRADE of evidence: low; strength of recommendation: weak).

  1. Postoperative strictures

6.1 Consider performing upper GI endoscopy, manometry, pH studies and barium swallow first in patients with post-fundoplication dysphagia, to understand the mechanism of dysphagia before dilatation or repeat surgery (GRADE of evidence: low; strength of recommendation: weak).

6.2 Consider treatment of concurrent delayed gastric emptying in order to reduce the need for redilatations (GRADE of evidence: low; strength of recommendation: weak).

6.3 Consider the use of balloon dilatation to 30-40 mm (as with achalasia) in patients with post-Nissen dysphagia (GRADE of evidence: low; strength of recommendation: weak).

6.4 Use steroid injections (0.5 mL aliquots of triamcinolone 40 mg/mL to the four quadrants) to reduce the frequency of repeat dilatations in anastomotic strictures refractory to initial dilatation approaches. This can be performed with a 4mm-long, 23-gauge needle immediately before bougie dilatation while leaving the needle in for at least 1 min to minimise leakage of the drug and ensure delivery of the full dose to the target area (GRADE of evidence: moderate; strength of recommendation: weak).

6.5 Consider using needle knife incision for anastomotic strictures as an alternative to dilatation (GRADE of evidence: moderate; strength of recommendation: weak).

  1. Post-radiation strictures

7.1 Consider a combined anterograde and retrograde dilatation (CARD) or rendezvous approach under general anaesthetic as an alternative to surgery in treatment of the completely obstructed oesophagus, where local expertise is available (GRADE of evidence: moderate; strength of recommendation: weak).

7.2 Use fluoroscopic guidance to assist with the rendezvous procedure (GRADE of evidence: moderate; strength of recommendation: strong).

7.3 Use a guidewire to navigate through the obstruction when using the CARD approach to re-establish luminal patency (GRADE of evidence: low; strength of recommendation: strong).

7.4 After gaining luminal patency using the CARD procedure, perform subsequent dilatation using either balloon or bougie (GRADE of evidence: moderate; strength of recommendation: strong).

  1. Caustic strictures

8.1 Perform upper gastrointestinal tract endoscopy within the first 12-48 hours after caustic ingestion (GRADE of evidence: moderate; strength of recommendation: strong).

8.2 Ensure timely management of oesophageal strictures with dilatation as this plays a key role in affecting patient outcomes (GRADE of evidence: moderate; strength of recommendation: strong).

8.3 Consider avoiding dilatation within 3 weeks of initial caustic ingestion (GRADE of evidence: low; strength of recommendation: weak).

8.4 Consider a time interval between dilatations of <2 weeks (GRADE of evidence: very low; strength of recommendation: weak).

  1. Refractory strictures

9.1 Inform patients about the lack of good quality evidence for best approach to treatment of refractory strictures (GRADE of evidence: low; strength of recommendation: strong).

9.2 Consider discussion with, and/or referral to, centres with expertise in treatment and follow-up of patients with refractory strictures (GRADE of evidence: low; strength of recommendation: weak).

9.3 Ensure optimal management of ongoing inflammation with high-dose PPI therapy before defining a stricture as refractory (GRADE of evidence: high; strength of recommendation: strong).

9.4 Consider alternative neuromuscular causes in patients with ongoing dysphagia despite a seemingly adequate oesophageal diameter (GRADE of evidence: low; strength of recommendation: strong).

9.5 Use fluoroscopic guidance during dilatation of refractory oesophageal strictures (GRADE of evidence: very low; strength of recommendation: weak).

9.6 Use either bougie or balloon dilators with the decision individualised on a case by case basis dependent on the nature (length, location, cause) of the stricture (GRADE of evidence: low; strength of recommendation: weak).

9.7 Use intralesional steroid therapy combined with dilatation in refractory strictures with evidence of inflammation (macro- or microscopically) on the assumption that anti-reflux therapy has been maximised previously with no benefit (GRADE of evidence: high; strength of recommendation: strong).

9.8 Consider incisional therapy in patients with refractory Schatzki’s rings and anastomotic strictures at centres experienced in the use of such techniques (GRADE of evidence: very low; strength of recommendation: weak).

9.9 Offer temporary placement of fully covered self-expanding removable stents in patients where previous methods have been unsuccessful in maintaining adequate oesophageal patency (GRADE of evidence: low; strength of recommendation: weak).

9.10 The optimum duration of stent placement is usually between 4 and 8 weeks, but may vary depending on stricture aetiology and length, and type of stent (GRADE of evidence: very low; strength of recommendation: weak).

9.11 Consider biodegradable stent placement to reduce the frequency of dilatation in selected cases (GRADE of evidence: low; strength of recommendation: weak).

9.12 Consider teaching selected, self-motivated patients, with short proximal strictures to self-bougienage (GRADE of evidence: very low; strength of recommendation: weak).

9.13 Offer surgery to patients who do not respond or are intolerant to other measures (GRADE of evidence: low; strength of recommendation: weak).

 

INTRODUCTION

Oesophageal dilatation is indicated in the treatment of symptomatic narrowing of the oesophagus, which may develop from of a wide range of anatomical and functional oesophageal disorders. The formation of benign strictures of the oesophagus is the end result of oesophageal inflammation and ulceration, which leads to deposition of collagen fibres that contract over time and cause narrowing of the oesophageal lumen.1 Reflux-induced strictures used to be a frequent indication for dilatation, but the increasing use of proton pump inhibitors (PPIs) has led to a relative decrease in their incidence.2 Other important causes of strictures include postoperative, post-endoscopic therapy (such as endoscopic resection (ER) and ablation), eosinophilic oesophagitis, post-radiation and corrosive strictures, as well as rings and webs.2-4 The characteristic symptom is dysphagia to solids more than liquids, in contrast to those with oesophageal motility disorders, in whom dysphagia to both solids and liquids occurs.1 In the latter group, dilatation does not consistently improve symptoms, with the exception of achalasia for which oesophageal dilatation is an effective treatment.5 The primary aim of oesophageal dilatation is to alleviate symptoms, permit maintenance of oral nutrition and reduce the risk of pulmonary aspiration.

GUIDELINE DEVELOPMENT

This guideline is endorsed by the Clinical Services and Standards Committee of the British Society of Gastroenterology (BSG) under the auspices of the oesophageal section of the BSG. It has been extensively updated and modified since the original version published in 2004. The methodology and reporting of the guideline were developed according to recommendations by BSG and the National Institute for Health and Care Excellence (NICE) with strict adherence to the Appraisal of Guidelines for Research and Evaluation (AGREE II) instrument as detailed below.

Assessing the quality of guidelines: AGREE II instrument

The purpose of the AGREE II instrument is to provide a framework to assess the quality of the guideline, provide a methodological strategy for its development and inform the reporting process of the guideline. It includes the following six domains which were used by our guideline development group (GDG): scope and purpose, stakeholder involvement, rigour of development, clarity and presentation, applicability and editorial independence.

Scope and purpose

This guideline will focus on the oesophageal dilatation procedure as a primary treatment for benign narrowing of the oesophagus using push or balloon dilators in adult patients (>18 years). Palliative treatment of malignant strictures and the use of stents as a primary treatment option are outside the scope of this guideline, but their role in dilatation failure will be discussed.6 Our objective is to provide a practical, evidence-based, guide for clinicians (gastroenterologists, upper GI surgeons, radiologists and non-medical endoscopists) on how to undertake oesophageal dilatation, as well as pre- and postprocedure considerations in order to maximise safety and efficacy in patients with dysphagia. This document is intended for use once a decision to perform oesophageal dilatation has been made. This decision ultimately resides with the caring clinician after discussion with the patient.

As the practice of pure radiological dilatation is appropriate in some circumstances but not always advantageous for reasons of convenience, the term endoscopist and endoscopic dilatation can sometimes be interchanged with radiologist and radiological dilatation throughout this document. The decision should rest with a team approach by endoscopists and radiologists in each centre.

In addition to description of the dilatation procedure, specific aspects of management for different types of strictures will also be covered. This will include peptic strictures, post-endoscopic therapy (such as endoscopic resection and ablation), eosinophilic oesophagitis, anastomotic, post-radiation and corrosive strictures as well as rings and webs. The dilatation procedure for oesophageal achalasia will also be described.

Stakeholder involvement

The GDG included individuals who are representative of all the relevant professional groups, including gastroenterologists (including one international expert), an upper GI surgeon, a radiologist and a nurse endoscopist. We also included a patient representative (who had had several dilatations for strictures and a perforation) and the chair of a relevant patient charity (Heartburn Cancer UK). All views were actively sought and incorporated in the guideline at every stage of its development through regular meetings and teleconference discussions.

Rigour of development

A systematic literature search strategy was developed with the aid of an expert librarian. We searched MEDLINE, Embase and the Cochrane Central Register of Controlled Trials (CENTRAL), from the database inception through to 31 October 2015 and updated 1 January 2017. Other sources searched included reference lists of identified primary journal articles. All the guideline questions were designed in PICO (Problem/population, Intervention, Comparator, Outcome) format and incorporated into an extensive search strategy (online supplementary appendix 1) using all possible combination of search terms (both as free text and—where applicable—as Medical Subject Headings). No language limits were applied. The search results were divided among GDG members, who independently screened titles and abstracts relevant to their writing sections (two members for each section). Studies were included if they reported data on any aspect of the dilatation procedure that is relevant to the guideline scope and purpose.

The quality of included evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system, which specifically separates the strength of evidence from the strength of a recommendation. While the strength of a recommendation may often reflect the evidence base, the GRADE system allows for occasions where this is not the case— for example, where it seems good sense to make a recommendation despite the absence of high-quality scientific evidence such as a large randomised controlled trial (table 1).

To achieve transparency and simplicity, the GRADE system classifies the quality of evidence in one of four levels—high, moderate, low and very low (table 1). Evidence based on randomised controlled trials begins as high-quality evidence, but our confidence in the evidence may be decreased for several reasons, including: study limitations; inconsistency of results; indirectness of evidence; imprecision; reporting bias. The GRADE system offers two grades of recommendations: ‘strong’ and ‘weak’. When the desirable effects of an intervention clearly outweigh the undesirable effects, or clearly do not, guideline panels offer strong recommendations. On the other hand, when the trade-offs are less certain—either because of low-quality evidence or because evidence suggests that desirable and undesirable effects are closely balanced—weak recommendations become mandatory. In addition to the quality of the evidence, several other factors affect whether recommendations are strong or weak, such as: uncertainty about the balance between desirable and undesirable effects, uncertainty or variability in values and preferences and uncertainty about whether the intervention represents a wise use of resources.

Areas of disagreement on the recommendation grade were resolved by discussion, using a Delphi process. The guideline drafts and final manuscript were critically reviewed by an international expert (PDS) to ensure broader applicability and rigour. It is expected that a review and updating of this guideline will be required in 5 years in order to account for new developments.

Clarity and presentation

We formulated recommendations that are specific and unambiguous. We considered both the general procedure of dilatation and specific aspects of stricture management according to the underlying health problem. Key recommendations are summarised at the beginning of the document.

Applicability

We do not expect any barriers or resource implications to the implementation of this guideline, because described assessment and treatment techniques are already being performed in clinical practice. We will provide a quick reference guide and suggest a minimum requirement for procedure documentation in order to facilitate audit and monitoring of outcomes in individual units.

Editorial independence

GDG members have declared their conflicts of interest. The views of any funding body did not influence the content of this guideline.

PATIENT PREPARATION

Oesophageal dilatation is best undertaken as a planned procedure in patients who have been appropriately investigated, prepared and consented. An assessment of the patient’s nutritional status and referral to a dietician should also be considered.

Predilatation investigations

(a) Should all strictures be biopsied before dilatation?

Obtain biopsy specimens from all strictures for histological analysis to exclude malignancy and eosinophilic oesophagitis7-9 (GRADE of evidence: moderate; strength of recommendation: strong).

Obtaining a definitive diagnosis before dilatation is desirable, because this will influence the overall management and estimation of perforation risk.8-10 Oesophageal biopsy samples can be safely obtained immediately before oesophageal dilatation7; however, if the stricture is tight or when the endoscopic features suggest malignancy, the results of biopsies are best awaited.4

Repeat biopsy after cross-sectional imaging (CT or with endoscopic ultrasound (EUS) in cases where biopsies are negative, but clinical or endoscopic features are atypical or suspicious for malignancy11 (GRADE of evidence: low; strength of recommendation: strong).

EUS may be a more sensitive test than CT, but passage of the EUS probe is often not successful in the case of a stricture.11

Obtain oesophageal biopsy specimens in young patients with dysphagia or history of food impaction to exclude eosinophilic esophagitis8 9 (GRADE of evidence: moderate; strength of recommendation: strong).

(b) Are there any other recommended tests?

Perform barium swallow in patients with suspected complex strictures (such as post-radiation therapy or history of caustic injury) in order to establish the location, length, diameter and number of strictures12 13 (GRADE of evidence: low; strength of recommendation: strong).

Barium swallow is also useful to evaluate the presence of associated pathology such as an oesophageal diverticulum or a hiatus hernia.12 13 This information will aid selection of the dilating technique, estimation of the number of sessions required and counselling the patient about the expected risks.13

Information and consent

The overall consent process should be in line with the published BSG guidance.14

(a) What information should patients be given?

Counsel all patients about the benefits and risks of dilatation and the likely need for multiple sessions before symptom resolution can be achieved (GRADE of evidence: low; strength of recommendation: strong).

Tailor information to the individual patient’s risk profile, based on the underlying cause, location, length and diameter of the stricture and coexistent adverse health problems (GRADE of evidence: low; strength of recommendation: strong).

Our patient representatives suggested that the use of a diagram to illustrate the location, length and shape of the stricture is desirable to enhance the patient’s understanding of the procedure. Moreover, the presence of a relative or a caregiver should be encouraged if deemed appropriate during the consent process.

Provide all patients with written information on oesophageal dilatation before the procedure and obtain written, signed consent. Inform patients about the perforation risk and the potential need for endoscopic or operative intervention should a perforation occur (GRADE of evidence: low; strength of recommendation: strong).

Inform patients— whenever appropriate—of any alternatives to dilatation, such as parenteral feeding or surgery in some cases (GRADE of evidence: low; strength of recommendation: strong).

(b) What are the possible complications?

Complications include pulmonary aspiration, bleeding, perforation, risks of sedation and chest pain15; the last of these being more common in patients with eosinophilic oesophagitis.16 17 A UK regional audit published in 1995 reported an overall perforation rate of 2.6% with a 30-day mortality of 1%.10 Perforation was less common following dilatation of benign strictures (1.1% with a mortality of 0.5%) than following dilatation and/ or intubation of malignant strictures (6.4% with a mortality of 2.3%).10 The risk of perforation was greater with less experienced endoscopists (performed <500 previous diagnostic endoscopies).10 Hernandez et al reported a perforation rate of 4 out of 348 procedures (1.1%); however, all these four perforations occurred when Maloney dilators (non-wire guided) were passed blindly into complex strictures. No perforations occurred with Savary-Gilliard (wire-guided) and balloon dilators.12 Hagel et al reported the most recent large retrospective case series of 1497 procedures on 368 patients over a 10-year period. Operators used Savary-Gilliard bougies (Cook Medical, Bloomington, Indiana, USA) or through the scope (TTS) balloons (Controlled Radial Expansion, CRE, Boston Scientific Ltd, Cork, Ireland and Eclipse Wire Guided Balloon Dilators, Cook Ireland Ltd, Limerick Ireland). Eight perforations (0.53%) occurred in malignant, post-radiation or caustic strictures. No perforations were reported in other types of strictures, such as peptic, postoperative and eosinophilic oesophagitis.18

The reported risk of perforation in achalasia has varied widely across studies from 0% to 8% (2-4% in most studies) with a mortality of 0-1%.19 20 Katzka et al19 pooled data from all 25 studies in the literature and reported a perforation rate of 2%; however, the balloon size, pressure, dilatation times and single or multiple dilatations varied in almost every study. The perforation rate is lower with a graded approach to balloon dilatation and in experienced hands.20

(c) What are the contraindications/cautions for stricture dilatation?

Do not perform oesophageal dilatation in patients with active or incompletely healed oesophageal perforation as it may extend the oesophageal defect and promote mediastinal soiling3 4 (GRADE of evidence: low; strength of recommendation: strong).

Perform dilatation in patients with a recent, healed perforation; recent upper gastrointestinal surgery; pharyngeal or cervical deformity; or bleeding disorders after careful consideration of the benefits, risks and alternatives of the procedure3 4 (GRADE of evidence: low; strength of recommendation: strong).

Dilatation may be performed in patients who are having concurrent radiotherapy.3 4

Fasting

Advise patients to fast for at least 6 hours before the procedure in order to ensure emptying of the oesophagus and stomach. Patients with achalasia are likely to have oesophageal stasis and are therefore required to fast for a longer time based on the clinician’s judgement3 4 (GRADE of evidence: low; strength of recommendation: strong).

Patient premedication

Inform patients that dilatation is likely to be uncomfortable, in particular, when push dilators are used rather than dilatation balloons (GRADE of evidence: low; strength of recommendation: strong).

Offer patients intravenous sedation with a benzodiazepine and an opioid analgesic as a minimum. Propofol sedation (delivered by a suitably qualified person), or a general anaesthetic are valid alternatives based on the clinician’s and patient’s preference, procedure complexity, as well as local availability and expertise (GRADE of evidence: low; strength of recommendation: strong).

Patients taking anticoagulants or antiplatelet agents and those at risk of endocarditis UK-based clinicians must adhere to the BSG and NICE guidelines on management of anticoagulation and antibiotic prophylaxis during endoscopy.21 22 Clinicians in other countries should follow the corresponding guidelines in their country or region of practice.22-24

THE DILATATION PROCEDURE

Personnel, training and equipment

(a) Who should perform dilatation?

Oesophageal dilatation should only be undertaken only by (or under direct supervision of) an experienced operator who performs sufficient numbers to maintain their skills. The operator should be supported by at least two assistants (one of whom must be a trained nurse) in the endos-copy/radiology room4 25 26 (GRADE of evidence: moderate; strength of recommendation: strong).

The specific number of dilatation procedures required each year to maintain the operator’s skills remains unknown. It is good practice for independent operators to audit their outcomes and be regularly involved in the care of patients with upper GI disorder. Professional bodies such as Joint Advisory Group on Gastrointestinal Endoscopy (JAG) may define the suitable number of procedures for training and maintenance of practice standards.

Ensure that trainees performing dilatation have adequate knowledge and understanding of the indications for, contraindications to, and complications of, this therapeutic procedure. An understanding of the steps for recognition and management of complications is required. Trainees should be familiar with different dilatation techniques as well as alternative and complementary treatment options27 (GRADE of evidence: moderate; strength of recommendation: strong).

It is estimated that less experienced endoscopists (who have performed fewer than 500 diagnostic upper endoscopy procedures) are four times more likely to cause a perforation than their more experienced colleagues.10 In the UK, the JAG stipulates that training on therapeutic endoscopy should be undertaken only after competency in diagnostic procedures is achieved (minimum of 300 procedures) and the former should take place under direct supervision.27 No formal guidelines exist for interventional radiologists, but a similar level of experience in diagnostic and interventional procedures is recommended. Close collaboration of the radiologists with interventional endoscopists and upper GI surgeons is essential for the appropriate management of complications.

Appropriate staffing and equipment are important for the provision of safe and successful therapeutic endoscopy procedures. Poor staffing levels are associated with worse outcomes from dilatation.10 Procedural assistants should be familiar with the dilatation equipment and capable of helping the operator in cases of an emergency. Qualified radiographers must be present when the procedure is performed under X-ray screening.4 10 25

(b) Where should the procedure be performed?

Perform the procedure in a dedicated, fully equipped endoscopy room with access to x-ray screening and surgical support,10 25 or a similarly equipped radiological suite (GRADE of evidence: moderate; strength of recommendation: strong).

Units must have an agreed protocol to follow in case of a perforation with clear identification of a qualified surgeon (on or off site) to manage this complication in cases where luminal treatment, such as a covered stent, is not feasible or appropriate6 10 (GRADE of evidence: low; strength of recommendation: strong).

Access to radiographic screening must be available to assist dilatation if there are difficulties in passing a guidewire or balloon catheter through the stricture.25 When a perforation occurs, prompt treatment should be started and the relevant surgical team must be informed immediately.25

Oesophageal dilators

There are two types of oesophageal dilators: the push (bougie) dilator and the balloon dilator.

Push dilators

Push dilators are either wire guided (metal olives, Celestin-type dilators or polyvinyl bougies) or non-wire guided (tungsten-filled weighted rubber bougies).28

Several models of wire-guided bougie dilators are available. The Savary-Gilliard (Cook Medical, Winston-Salem, North Carolina, USA) dilators are polyvinyl chloride, latex-free cylindrical solid tubes with a central channel to accommodate the guidewire. They are the most widely used (5-20 mm diameter). Each dilator has a 20 cm tapered tip and a radio-opaque band at the widest point of the dilator to aid radiological localisation. American Dilatation System (ConMed, Utica, New York, USA) and SafeGuide dilators (Medovations, Milwaukee, USA) are similar, but are totally radio-opaque throughout their length.28 Bougie dilators have external markers indicating the distance from the tip (American System) or from the point of maximal diameter (Savary-Gilliard) or both (SafeGuide). The InScope Optical Dilator (Ethicon Endosurgery Inc, Blue Ash, Ohio, USA) is a flexible, transparent, bougie with three dilating segments fitted over a standard endoscope to allow sequential dilatation under direct vision, but data on its efficacy are scarce.29

The Eder-Puestow dilators comprise a series of graduated metal olives (6.6-19.3 mm diameter) mounted on a flexible shaft. At one time, this was the only system available for dilating complex or resistant strictures, but is now rarely used.

Non-wire-guided weighted bougies are passed blindly after the application of local anaesthetic while the patient is in a sitting position. This approach has been used for self-dilatation in carefully selected patients, but it is seldom used now owing to concerns about safety.28 The Maloney dilator was the most commonly used. It has a tapered tip and is available in multiple sizes. Older versions were internally weighted with mercury, which has now been replaced by tungsten because of concerns about leakage and disposal of mercury.

Balloon dilators

Through the scope (TTS) balloon dilators are available in a variety of designs, lengths and diameters from various manufacturers. They are designed to pass through the endoscope with or without wire guidance so that dilatation can be observed. The balloon is made of low-compliance, inflatable, thermoplastic polymers that allow uniform and reproducible expansion to the specified diameter. Most balloons allow for sequential expansion to multiple diameters. Larger ranges of wire-guided balloons are available for non-endoscopic dilatation under fluoroscopy. The balloon size needs to be carefully matched to the size of the stricture (see below). Dilating balloons are expanded by pressure injection of liquid (eg, water, radio-opaque contrast) using a handheld accessory device. Inflation with radio-opaque contrast allows for fluoroscopic observation. The hydraulic pressure of the balloon is monitored manometrically to gauge the radial expansion force. Balloon dilators are single-use only.28

For achalasia dilatation, large-diameter (30, 35 and 40 mm) polyethylene balloon dilators with radio-opaque markers are used.28 They are all wire-guided, single use, and do not pass through the endoscope. They are positioned using fluoroscopic guidance, and balloon insufflation pressure is monitored manometrically.28

(a) Is there a difference in clinical outcomes between balloons and bougie dilators?

Use either balloon or wire-guided bougie dilators to perform oesophageal dilatation30-32 (GRADE of evidence: high; strength of recommendation: strong).

There is no difference in clinical outcomes—in particular, safety and efficacy, between wire-guided bougie and balloon dilators. Hence the choice should be based on clinician’s preference, local expertise, equipment availability, cost and the availability of robust methods of decontamination of reusable medical devices as many push dilators are not single

Three randomised controlled trials compared these two techniques and found no difference in efficacy for dysphagia relief or safety at 1 year. Another retrospective study compared Maloney, balloon-type (both the hydrostatic and pneumatic type) and Savary-Gilliard dilators in 102, 156 and 90 sessions, respectively. The risk of oesophageal perforation was higher with Maloney dilators when passed, blindly, into complex strictures; hence they should be avoided in these cases, and in patients with a tortuous oesophagus and large hiatus hernia.12 Savary-Gilliard and balloon dilators are currently the most frequently used.28 Although balloon dilators allow the procedure to be performed under direct vision, they are more costly than push dilators28 but there is no direct cost-effectiveness comparison of the two techniques in clinical practice.

 

to be continued…